Status:
RECRUITING
KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting
Lead Sponsor:
University Hospital of Cologne
Conditions:
Nutrition
Muscle Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A physiological human nutrition includes circadian feeding and nighttime fasting during sleep. There is increasing evidence, that this natural fasting episode over nighttime majorly contributes to rep...
Detailed Description
There is increasing evidence that a circadian rhythm of feeding (cyclic feeding) could be beneficial for critical ill patients. Cyclic feeding and fasting are assumed to have positive effects on the g...
Eligibility Criteria
Inclusion
- written informed consent to participate in this study
- admission to ICU
- enteral nutrition
Exclusion
- Severe liver dysfunction / liver failure (Child Pugh \>7 points / category B)
- Severe kidney dysfunction (KDIGO stage 3)
- Total pancreatectomy / insulin dependent diabetes mellitus (IDDM)
- Pregnancy / lactation
- Hemoglobin concentration \< 80g/l
- Severe metabolic disorders / severe autoimmune diseases
- Refractory metabolic or respiratory acidosis
- Dysfunction of mitochondrial transport of fatty acids
- Dysfunction of oxidation of fatty acids
- Dysfunction of gluconeogenesis, production and reduction of ketones
- Intermittent Porphyria
- Severe cardiac arrhythmias / cardiomyopathy
- Contraindication against enteral nutrition
- Lack of informed consent
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06535815
Start Date
September 1 2023
End Date
March 1 2026
Last Update
August 6 2024
Active Locations (1)
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1
Department of Anesthesiology and Intensive Care Medicine
Cologne, North Rhine-Westphalia, Germany, 50937